CordenPharma & Certest: A Powerful Partnership Unleashing the Potential of Patented Ionizable Lipids in LNP Formulation

6 June 2024 – Basel, Switzerland / Zaragoza, Spain CordenPharma, a global CDMO leader in the manufacture of Drug Substances (APIs) for complex modalities (such as peptides, GalNAc, lipids, etc.), Lipid NanoParticles (LNPs) containing xRNA / xDNA, and injectable Drug Products, and Certest, a Spanish company focused on the development of new products with special emphasis in Drug Delivery with LNPs and API synthesis, have signed a partnership agreement.

The partnership, signed on 7 May 2024, aims to add ionizable lipids to CordenPharma’s complex LNP formulation services, the missing key element needed to close the gap in its formulation offering to support biotech and pharmaceutical companies with the development, discovery, and manufacturing of xRNA / xDNA from early clinical phase to commercial. The partnership complements CordenPharma’s recently announced strategy to address targeting with peptide-decorated LNPs, and opportunities to enhance mRNA transfection with β-sitosterol.

Under the terms of the agreement, Certest will provide access to their unique ionizable lipids platform, well supported by in vitro / in vivo and tox data. In the alliance, thanks to its four decades of experience in lipids development and manufacturing, CordenPharma will leverage cGMP manufacturing capacities, regulatory know-how, and market access to ensure high-quality GMP supply for their customers’ journey to market.

Dr. Matthieu Giraud, CordenPharma’s Senior Director, Global Lipids & Carbohydrates Platform, commented: “Many therapeutic domains can benefit from the newly introduced LNP formulation that proved to be successful during the pandemic. At CordenPharma, we aim to consider independently each of the four pillars of an LNP formulation, namely the lipid functional excipients, to provide our customers with the most effective support in solving their therapeutic formulation challenges. This partnership augments our offer with a lean and attractive approach to LNP formulation that also reduces the growing IP challenges in the market.”

Nelson Fernandes, CEO of Certest, commented: “The world of lipid nanoparticles is revolutionizing the pharmaceutical industry today. The results have been overwhelmingly positive, and advancements in the formulation of LNPs, along with the development of a robust library of ionizable lipids, are set to redefine the paradigm of the current situation.

At Certest, we offer a powerful delivery platform, thanks to our ionizable lipids, that will enable clients to overcome nearly all therapeutic challenges. This collaboration is going to be a significant advancement for our clients.”

About CordenPharma

CordenPharma is a CDMO partner supporting biotech and pharma innovators of complex modalities in the advancement of their drug development lifecycle. Harnessing the collective expertise of the teams across its globally integrated facility network, CordenPharma provides bespoke outsourcing services spanning the complete supply chain, from early clinical-phase development to commercialization.

With scientific expertise and partnership at its core, CordenPharma provides customers with high-value, end-to-end services with a strategic focus on Peptides, Oligonucleotides, customized Lipid Excipients, Lipid NanoParticles (LNPs), sterile Injectables, and the extensive supply of Small Molecules (both Highly Potent and Regular Potency).

The CordenPharma Group is comprised of 11 facilities across Europe and North America. In the 2023 financial year, the organization generated sales of 880 million Euros and had over 3,000 employees.

Please visit cordenpharma.com for more information.

About Certest

Certest Pharma specializes in advanced lipid nanoparticle technology, focusing on the development of effective and targeted LNPs for next-generation medicines. Certest’s licensable technology includes top-performing ionizable lipids, the main asset, and LNP formulations with excellent performance in vivo and which can induce extrahepatic delivery.

Having an extensive scientific background and several collaborations, Certest Pharma offers cutting-edge solutions with different payloads of RNA therapies.

Certest Pharma is the fourth business unit of Certest Biotec S.L, established in Zaragoza in 2002 as an innovative and technology-based company. With more than 130 countries as destinations, Certest has always based its growth on the research and development of new products and the exploration of new market niches with a great emphasis in control of starting materials.

Visit pharma.certest.es for more information.

CordenPharma Media Contacts

North America: abby.thompson@cordenpharma.com I Europe & Asia: eva.schaub@cordenpharma.com